Tai Qingping, Shao Hua, Liu Yanli, Li Enshan, Zhao Rongfei
Department of Abdominal Surgery, Linyi Cancer Hospital, Linyi, China.
J BUON. 2019 Sep-Oct;24(5):2006-2012.
To compare the clinical efficacy and safety of FOLFOX6 regimen and docetaxel-cisplatin-fluorouracil (DCF) regimen as neoadjuvant chemotherapy (NACT) combined with radical gastrectomy in treating advanced gastric cancer.
The clinical data of 96 patients with advanced gastric cancer admitted and subjected to NACT combined with radical gastrectomy in our hospital from September 2013 to September 2017 were collected, and the patients were divided into FOLFOX6 group (n=48) and DCF group (n=48) according to the NACT regimens received. The radical gastrectomy was performed about 4 weeks after NACT. After operation, the NACT regimens were continued. The efficacy of NACT, adverse reactions, operation conditions, postoperative recovery and prognosis of the patients were observed and recorded. The patients were followed up by means of outpatient visits and telephone calls, so as to understand their postoperative survival and disease development.
The general clinical features of the patients were comparable, and there was no death case in the perioperative period in both groups. The clinical response rates were 47.9% and 52.1% in FOLFOX6 group and DCF group, respectively, and the disease control rates were 91.7% and 89.6% in FOLFOX6 group and DCF group, respectively (p>0.05). Thirty-nine and 45 cases of adverse events occurred in FOLFOX6 group and DCF group, respectively, during NACT. Among them, there were 33 cases in grade I, 37 cases in grade II, 6 cases in grade III and 8 cases in grade IV. FOLFOX6 group had remarkably fewer cases of nausea and vomiting, leucopenia and thrombocytopenia than DCF group (p=0.004, p<0.001, p=0.030), while no statistically significant differences were discovered in other adverse reactions (p>0.05). The differences in operation time, intraoperative blood loss, number of blood transfusion, surgical approach, number of dissected lymph nodes, surgical margin and number of palliative surgery between the two groups were not statistically significant (p>0.05). Moreover, there were no statistically significant differences in gastrointestinal function recovery time, length of hospital stay and complications after operation (p>0.05). The patients were followed up for 12-60 months, and it was found that the 1-year survival rates were 91.7% (44/48) and 95.8% (46/48), respectively, and the 3-year survival rates were 62.5% (30/48) and 70.8% (34/48), respectively, in the two groups. According to log-rank test, the differences in the survival rates between the two groups of patients were not statistically significant (p=0.274).
The FOLFOX6 regimen and DCF regimen as NACT combined with radical gastrectomy have curative effects in treating locally advanced gastric cancer, preferable clinical response rate and disease control rate can be obtained, and the adverse reactions of the chemotherapy are tolerable. The patients receiving the FOLFOX6 regimen show a better tolerance, manifesting that the FOLFOX6 regimen is safer, which is worthy of clinical popularization.
比较FOLFOX6方案与多西他赛-顺铂-氟尿嘧啶(DCF)方案作为新辅助化疗(NACT)联合根治性胃切除术治疗进展期胃癌的临床疗效及安全性。
收集2013年9月至2017年9月在我院接受NACT联合根治性胃切除术的96例进展期胃癌患者的临床资料,根据接受的NACT方案将患者分为FOLFOX6组(n = 48)和DCF组(n = 48)。NACT后约4周进行根治性胃切除术。术后继续原NACT方案。观察并记录患者NACT的疗效、不良反应、手术情况、术后恢复及预后。通过门诊随访和电话随访患者,了解其术后生存及疾病进展情况。
两组患者一般临床特征具有可比性,两组围手术期均无死亡病例。FOLFOX6组和DCF组的临床缓解率分别为47.9%和52.1%,疾病控制率分别为91.7%和89.6%(p>0.05)。NACT期间,FOLFOX6组和DCF组分别发生39例和45例不良事件。其中,Ⅰ级33例,Ⅱ级37例,Ⅲ级6例,Ⅳ级8例。FOLFOX6组恶心呕吐、白细胞减少和血小板减少的病例明显少于DCF组(p = 0.004,p<0.001,p = 0.030),而其他不良反应差异无统计学意义(p>0.05)。两组手术时间、术中出血量、输血量、手术方式、清扫淋巴结数目、手术切缘及姑息性手术例数差异均无统计学意义(p>0.05)。此外,两组术后胃肠功能恢复时间、住院时间及并发症差异均无统计学意义(p>0.05)。对患者随访12 - 60个月,发现两组1年生存率分别为91.7%(44/48)和95.8%(46/48),3年生存率分别为62.5%(30/48)和70.8%(34/48)。经对数秩检验,两组患者生存率差异无统计学意义(p = 0.274)。
FOLFOX6方案和DCF方案作为NACT联合根治性胃切除术治疗局部进展期胃癌均有疗效,可获得较好的临床缓解率和疾病控制率,化疗不良反应可耐受。接受FOLFOX6方案的患者耐受性更好,表明FOLFOX6方案更安全,值得临床推广。